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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 4-92
Standard
ANSI ADA Standard No. 88-2000 (R2012) Dental Brazing Alloys
Scope/Abstract
This standard specifies requirements and test methods for brazing filler alloys suitable for use in brazing cast dental restorations.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3060 Alloy, Other Noble Metal Class 2 EJS
§872.3710 Alloy, Metal, Base Class 2 EJH
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Class II Special Controls
Guidance Document: Dental Noble Metal Alloys Document issued on: August 23, 2004

Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Dental Base Metal Alloys Document issued on: August 23, 2004
FDA Technical Contact
 Michael Adjodha
  FDA/OC/CDRH/OPEQ/OHTI/DHTIB/
  301-796-6276
  michael.adjodha@fda.hhs.gov
Standards Development Organizations
ADA American Dental Association http://www.ada.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Dental/ENT
*These are provided as examples and others may be applicable.
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